Renoprotection by Pentoxifylline and Angiotensin Receptor Blocker in Chronic Kidney Disease (CKD)

NCT01377285 | Unknown Phase 4

• 1 other identifier: 200809041M
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial to investigate the renoprotective efficacy of combined pentoxifylline (PTX) and angiotensin receptor blockers (valsartan), compared with placebo and valsartan in 700 patients with Chronic Kidney Disease (CKD) stages 3 and 4. The effect on cardiovascular comorbidity will also be observed. The observation period will be 3 years. The primary endpoints consists of doubling of serum creatinine, end stage renal disease (ESRD), and death from any cause. The secondary endpoints include changes of microalbuminuria or proteinuria, serum and urinary levels of TNF-a(tumor necrosis factor-alpha ), MCP-1(monocyte chemotactic protein), TGF-beta1(transforming growth factor ), collagens III (amino terminal peptide of procollagen III) and IV, and fibronectin, urinary N-acetyl-beta-glucosaminidase, as well as serum fibrinogen and high-sensitive CRP(C reactive protein), and development of heart failure, nonfatal myocardial infarction, and stroke or transient ischemic attack.

Conditions

Chronic Renal Failure

Keywords

chronic kidney disease; pentoxifylline; angiotensin receptor blockers(ARB)

Outcome Measures

Primary Outcomes (1)

• doubling of serum creatinine, ESRD, and death from any cause

  3 years

Secondary Outcomes (1)

• changes of microalbuminuria or proteinuria, and development of heart failure, nonfatal myocardial infarction, and stroke or transient ischemic attack.

  3 years

Study Arms (2)

ARB & Pentoxifylline

EXPERIMENTAL

angiotensin receptor blockers(ARB)and Pentoxifylline 400mg tablet (If CKD3 1# BID(Bi in die=two times a day); CKD4 1# QD(quaque die=one time a day); CKD5(estimated Glomerular filtration rate,eGFR\<15ml/min/1.73 m2) 1# QOD(Every other day).

Drug: ARB; Drug: Placebo (for Pentoxifylline)

ARB & Placebo

ACTIVE COMPARATOR

angiotensin receptor blockers(ARB) and Placebo tablet(If CKD3 1# BIDBi in die=two times a day); CKD4 1# QD(quaque die=one time a day); CKD5(estimated Glomerular filtration rate,eGFR\<15ml/min/1.73 m2) 1# QOD(Every other day).

Drug: Pentoxifylline; Drug: Placebo (for Pentoxifylline)

Interventions

ARB DRUG

Angiotensin II receptor antagonists ,these medicines have names that end in "sartan".For examples:losartan,candesartan,irbesartan,olmesartan,telmisartan,valsartan

Also known as: angiotensin receptor blockers(ARB)

ARB & Pentoxifylline

Pentoxifylline DRUG

This medication is used to improve the symptoms of a certain blood flow problem in the legs/arms (intermittent claudication due to occlusive artery disease)

Also known as: Trental

ARB & Placebo

Placebo (for Pentoxifylline) DRUG

Sugar pill manufactured to mimic Pentoxifylline 400mg tablet

Also known as: Placebo(non treatment)

ARB & Pentoxifylline; ARB & Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Renal replacement therapy is not expected within the forthcoming 12 months.
• Currently under angiotensin receptor blockers(ARB) therapy for at least 8 weeks, with systolic blood pressure\<150 mmHg, diastolic blood pressure \<90 mmHg
• Renal function has been stable for at least 8 weeks (fluctuation\<25% of baseline) at the time of screening

You may not qualify if:

• Type I DM patients
• Patients with history of allergy to pentoxifylline or methylxanthine derivatives (such as caffeine, theophylline)or those who have been taking pentoxifylline or dipyridamole as a treatment for chronic disease in the preceding 3 months at screening.
• Patients have been taking ACE inhibitors, renin inhibitors (eg. Rasilez); and direct vasodilators (e.g., hydralazine and minoxidil) at the time of screening
• Females in nursing or pregnancy, or preparing for pregnancy within the next three years.
• Obstructive uropathy.
• Active gastrointestinal bleeding Active peptic ulcer, patients with active bleeding or bleeding tendency and patients under antiplatelet or anticoagulant therapy,except for aspirin 100 mg, clopidogrel 75 mg.
• Unable to stop chronic immunosuppressive therapy or NSAID; or current use of phosphodiesterase inhibitors other than pentoxifylline (eg., dipyridamole)
• Congestive heart failure of functional class III or IV.
• Unstable angina, myocardial infarction, coronary artery bypass graft surgery, or percutaneous coronary intervention, within the past 3 months prior to signing for informed consent.
• Cerebral vascular diseases within the past 3 months prior to signing for informed consent.
• Retinal hemorrhage within the past 3 months prior to signing for informed consent.
• Known or suspected secondary hypertension (e.g., primary aldosteronism, renovascular hypertension, and pheochromocytoma).
• Poor glycemic control (HbA1c\>8.5%)
• Liver cirrhosis or hepatic dysfunction as defined by abnormal liver function test
• Biliary obstructive disorders (e.g., cholestasis).

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Far Eastern Memorial Hospital: collaborator
• Mackay Memorial Hospital: collaborator
• Taipei Medical University Hospital: collaborator
• Shin Kong Wu Ho-Su Memorial Hospital: collaborator
• Cathay General Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Interventions

Angiotensin Receptor Antagonists; Pentoxifylline

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yung-Ming Chen, M.D.; PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yung-Ming Chen, Professor

CONTACT

00886-2-23123456; chenym@ntuh.gov.tw

HUI JEAN CHANG

CONTACT

00886-2-23123456; 907895@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 21, 2011
• Study Start: June 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 14, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)